Shots: The NDA filing is based on the P-III RESTORE-IMI 1 study results, assessing Imipenem/Cilastatin + Relebactam (IMI/REL) vs imipenem/cilastatin + colistin (IMI+CST) in patients with gram-negative bacterial infections The […]readmore
Tags : Merck
Shots: The positive opinion is based on P-III KEYNOTE-407 trials results assessing Keytruda + CT (carboplatin/paclitaxel/nab-paclitaxel) vs CT monothx. in patients with msq NSCLC The P-III KEYNOTE-407 trials resulted in […]readmore
Shots: The BT designation is based on P-I/II and P-II results assessing four lots of V114 in healthy adults and infants, demonstrating non-inferiority data in patients FDA’s BT designation is […]readmore
Shots: NGM to receive $20M as total deal value with anoption to participate in P-III trial of MK-3655 with equal cost and revenue sharing. Merck to get exclusive worldwide rights […]readmore
Shots: • Out of 5 approvals three are for NSCLC patients, one for Melanoma and one for Microsatellite Instability-High (MSI-H) solid tumor patients • Keytruda got approved as monotherapy in […]readmore
Shots: Vaxelis a hexavalent combination vaccine is approved for the prevention of Diphtheria, Tetanus, Pertussis, Poliomyelitis, Hepatitis B and Haemophilus influenzae type B in children from 6 wks. to 4 […]readmore
Shots: The P-III JAVELIN Ovarian 100 study involves assessing of avelumab + and/or following Pt-based carboplatin/paclitaxel CT in 998 patients with LA or metastatic (Stage III or Stage IV) epithelial ovarian cancer, […]readmore
Shots: The approval is based on P-II CITN-09/KEYNOTE-017 study assessing Keytruda in 50 patients with recurrent LA or mMCC who had not received prior systemic therapy P-II CITN-09/KEYNOTE-017 study results: […]readmore
Shots: The approval is based on P-III SOLO-1 trial assessing Lynparza (300 mg bid) as maintenance monothx vs PBO in 391 patients in ratio (2:1) with BRCAm advanced ovarian cancer following first-line Pt-based […]readmore
Shots: The approval is based on P-III EORTC1325/KEYNOTE-054 trial assessing Keytruda (IV 200mg, q3w) as adjuvant therapy vs PBO, in 1,019 patients in ratio (1:1) with completely resected melanoma (stage IIIA [>1 mm […]readmore